Single use safety needle guard

ABSTRACT

A Hypodermic Needle Safety Guard intended for sharps prevention and safer hypodermic needle use during all stages of an injection process. The Safety Guard may include two symmetrically positioned multi-featured arms that include spring tension, multiple hinges and needle locks. These arms may connect a proximal Luer body and a distal alignment tip thereby enabling the guard to open, close and lock on a needle when manual pressure is applied. The Guard position during hypodermic needle use tends to prevent sharps injury by adjusting the exposure of the Needle tip.

BACKGROUND

There are multiple types of safety Guards that are integrated with orattach to hypodermic Needles of syringes in the market today. Guards areprimarily used in the transport and storage of hypodermic needles.Guards tend to not remain in use during the filling and use of thesyringe, and tends to require placement of a user's hands near theNeedle Tip to remove and place the Guard onto a Needle, and increasingthe risk of accidental injury or contamination. There exists a need fora Needle Guard that stays in place on a syringe and needle, and that issafer for users.

SUMMARY

In an embodiment of the invention, there is a Guard that remains on ornear the Needle during all phases of the use of a hypodermic Needle. Inthe embodiment, the Guard changes shape during its use or operation,such as when the Needle is stored, filled, transported, used orprevented from use.

In an embodiment, a single use Needle safety Guard covers a hypodermicNeedle that prevents the Needle from causing sharps injury such asduring transport and storage, and still allows the Needle to be usedwithout manual detachment of the Guard from the Needle or syringe. TheGuard tends to be useful from storage to filling a syringe with fluid,to transporting it around and the administration of the fluid, topotentially also before “locked” for disposal. Such a Guard can functionto prevent sharps injuries during the use of a hypodermic Needle beforeits disposal, and alternate embodiments can also function alternativelyor additionally to prevent secondary use of the Needle when having.

In an embodiment, there is a hypodermic or injectable Needle Guard,configured to reduce the possibility of sharps injuries and increasingoverall use safety. The Guard of the embodiment can be permanentlyaffixed to a Needle body, and configured to form during the use of theNeedle to provide greater use safety. The Guard can be configured tochange form from a first form for storage/travel, to a second form forfilling/administration and to a third form for resisting further use. Inthe embodiment, form can be changed by means of integral or featureformed hinges, and with positional Needle locks. Such form changes tendto allow a greater degree of flexibility and safety during the use cycleof a Needle because as so configured, the Guard does not have to leaveor be detached off the Needle or syringe. A Guard of an embodiment canfurther provide functional benefits in the administration of the fluidbecause it stays in place. For example, a Guard face can be configuredto expand the pressure footprint on skin surface during use to lessenthe feeling associated to an injection. In an embodiment, a single usefeature can be achieved by means of a Guard having one time lockingfeatures that, for example, position around the Shaft of a Needle makingsecondary use only possible with the destruction of the Guard.

In an embodiment, there is a guard apparatus for a hypodermic needle.The guard comprises a needle surround adapted to a needle shafttherethrough, and at least two arms extending from the needle surround,each arm moveable from a first position to a second position, and wherein the first position each arm runs substantially the length of theneedle shaft. When the at least two arms are moved into the secondposition, the arms bring the needle surround around the needle shaft toallow a portion of the length of the needle shaft therethrough.

Each of the at least two arms may be adapted to reshaping each arm fromthe first position to the second position. The reshaping of each arm maybe provided by two or more hinges on each arm. A first hinge may beproximate to the needle surround, and a second hinge may be positionedfurther along each arm distal from the first hinge.

An arm may be molded plastic, and each hinge is provided by a thinnedsection of plastic that is more flexible than other sections of thearms. The thinned section of plastic the arms hinge may be manufacturedwith forms creating intrinsic varying spring values. The needle surroundmay be molded plastic. The arms and the needle surround may be moldedtogether.

An arm may have thereon a retention feature adapted to removably engagewith the needle shaft when the arm is in the first position, and whenthe retention feature is removably engaged with the needle shaft, thefeature may provide a resistive force against moving the arm from thefirst position of the arm running substantially along the length of theneedle shaft, to the second position. Upon a releasing force overcomingthe resistive force is applied, the retention feature may be disengagedfrom the needle shaft to permit the retention feature to move to thesecond position. An arm may comprise a second retention feature. Thesecond retention feature may be engagable with the needle when the armis moved to a third locked position. The second retention feature mayprovide a locking force greater than the releasing force, to maintainthe arm in a locked position whereby the arm runs substantially alongthe length of the needle shaft. The retention feature may be triangularin shape. The retention feature may be less than 60% of the diameter ofthe needle shaft. The second retention feature may be triangular inshape. The second retention feature may be 60% or greater than thediameter of the needle shaft.

The first and second retention features may each be grooves molded ontoa retention feature arm extending from the arm. The retention featurearm may be molded together with the arm. The second retention featuremay be closer to the arm than the first retention feature.

The first retention feature may comprise a first set of grooves, and thesecond retention feature may comprise a second set of grooves. Eachgroove of the first set of grooves and each groove of the second set ofgrooves, respectively, may be molded onto a separate retention featurearm extending from the arm. Each such retention feature arms may bemolded together with the arm. Each groove of the second set of groovesmay be closer to the arm than each groove of the first set of grooves.

The first retention feature may comprise a triangular-shaped engagementblock on a first retention feature arm extending a first distance fromthe arm. The second retention feature may comprise a triangular-shapedengagement block on a second retention feature arm extending a seconddistance from the arm. The second distance may be shorter than the firstdistance.

The guard apparatus may be integrated with a needle body housing of thehypodermic needle connected to the needle shaft. The guard apparatus maybe attachable to a needle body housing of the hypodermic needleconnected to the needle shaft. The guard apparatus may be attachable tothe needle body housing by a Luer lock.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric view of a Needle Guard assembled on to a Needle;

FIG. 2 is another isometric view of the assembled Needle Guard andNeedle of FIG. 1;

FIG. 3 is a top view of the Needle Guard assembly of FIG. 1;

FIG. 4 is a front view of the Needle Guard assembly of FIG. 1;

FIG. 5 is a rear view of the Needle Guard assembly if FIG. 1;

FIG. 6 is a section view of the Needle Guard assembly of FIG. 1;

FIG. 7 is another section view of the Needle Guard assembly of FIG. 1;

FIG. 8 is a side view of the Needle Guard assembly of FIG. 1, with theGuard in a first position;

FIG. 9 is another side view of the Needle Guard assembly of FIG. 1, withthe Guard in a second position;

FIG. 10 is another side view of the Needle Guard assembly of FIG. 1,with the Guard in a third position;

FIG. 11 is a section view of Guard lock features of an embodiment of aNeedle Guard assembly, as shown behind the front face;

FIG. 12 is an isometric view showing a Needle and a Needle Guardassembly in exploded view;

FIG. 13 is an isometric view showing a Needle Guard assembly in relationto an hypodermic syringe body;

FIG. 14 an isometric view showing a Needle Guard assembly assembled toan hypodermic syringe body;

FIG. 15 is a section view of the assembled Needle Guard assembly andhypodermic syringe body of FIG. 14;

FIG. 16 is an isometric view of the Needle Guard assembly of FIG. 1 inthe partially open position;

FIG. 17 is an isometric view of the Needle Guard of FIG. 1 in apartially open position;

FIG. 18 is an isometric view of an embodiment of a Needle Guard assemblyin a first position;

FIG. 19 is a top view of the Needle Guard Needle assembly of FIG. 18 ina second position;

FIG. 20 is a front section view of an embodiment of a Needle Guardassembly having alternate shaft lock features;

FIG. 21 is an isometric view of an embodiment of shaft lock features ina Needle Guard assembly.

DETAILED DESCRIPTION

It will be appreciated that for simplicity and clarity of illustration,where considered appropriate, reference numerals may be repeated amongthe figures to indicate corresponding or analogous elements or steps. Inaddition, numerous specific details are set forth in order to provide athorough understanding of the exemplary embodiments described herein.However, it will be understood by those of ordinary skill in the artthat the embodiments described herein may be practiced without thesespecific details. In other instances, well-known methods, procedures andcomponents have not been described in detail so as not to obscure theembodiments described herein. Furthermore, this description is not to beconsidered as limiting the scope of the embodiments described herein inany way, but rather as merely describing the implementation of thevarious embodiments described herein.

In an embodiment of the invention is an attachable Needle Guard for ahypodermic Needle or an integrated Needle and Guard that protects usersfrom accidental sharps injuries, where once assembled onto the Needle,the Guard is designed to be permanently attached to the needle. In anembodiment, a Guard can be made up of two arms that extend from acentral body over two or more sides of a Needle Shaft and extend forwarda solid body with a central Needle hole and in front of the Needle Tip.The arms extending forward are capable of flexing and reshaping, such asby means of hinges, which may be integral. In an embodiment, thesehinges can be thinned areas of plastics part that allow it to flex andreshape. As configured, when a force is applied to the front of a Guard,portions of the arms on the Guard can flex away from the Needle Shaft byway of the hinges. The direction(s), angle(s) and/or position(s) of flexcan be controlled by the initial forming or manufacturer of the Guard.For example, during the molding process the arms may be positioned sothat when pressure is applied to the front of the Guard, the arms canflex open in an outward direction to allow the Needle to extend past theface of the Guard (or to withdraw the face of the Guard so that theNeedle is exposed). When the force is removed from the front face of theGuard, the arms can be configured so that they return to a partiallyopen form and protect the Needle and the its Tip. In an embodiment, theposition can be controlled by lock features that extend from the innersurfaces of the arms. These locks can be positional. The lock featuresposition can be configured around the Needle Shaft, such as for fortemporary and permanent locks. In an embodiment, the temporary locks canengage to prevent sharps injuries during transport or general use, whilethe permanent locks can engage so that the Needle can be disposed of,such as after use so as to resist re-use. In an embodiment, the lockscan be fully engaged by means of pinching the arms together and towardsthe Shaft. When the arms are pinched inwards towards the Needle Shaft,the arms change form from capable of opening, such as in a concaveshape, to one where they are locked by the locking features and becomeresistant to opening, such as in a convex shape. The Locking feature forthe needle shaft may be comprised of multiple parts on each arm. In thecurrent embodiment there is a primary and secondary feature. The primaryfeature provides the initial needle hold position and then a secondarypermanent lock. The difference in the position and locking functions aresurface features. These features vary in height providing differentdegrees of interference during assembly. Ie. When the face of the Guardis pressed, the Guard opens and the Needle extends. The interferencerequired for this change in shape is minimal. When the Guard is pinchedfor disposal the amount of interference is greater and is intended tonot be overcome. Further the shape of the interference during thedisposal step can be linear or inclined to allow for constant orincreasing force requirements. The current embodiment incorporates atriangular shaped feature resulting in an increasing force requirement.Secondary to the primary feature is an additional feature above oroffset from the first feature. It's positioning creates a lock to thefirst feature for the needle. If through deformation the Guard ismanipulated the Needle is locked in position permanently by thesecondary feature. This feature may additionally be shaped to provideconstant and increasing force requirements. In addition to the generalsafety function of the Needle Guard, the Guard can also provide agreater surface area through the face of the guard on the skin when theNeedle is inserted into it. This increased surface area can tend toreduce the amount of pain the user feels during the administration of aNeedle.

For example, in an embodiment the form of a needle guard can changeduring its use cycle by means of applied pressure. When the front faceof the guard is placed in contact with a body and force is then appliedto the needle body, the arms of the Guard will open and the Needle Tipis then able to extend past the face of the Guard. As the Guard armsopen the spring features of the integral hinges are compressed. In suchan embodiment, the force applied to the Needle Body so that the NeedleTip extends into the subject body must be greater than the force neededfor the spring in the hinge to collapse or open. When the forward movingforce is removed, or is less than the spring hinge force the Guard Armsbegin to return to substantially their initial extended form. Force willnot be stored in the Spring Arms if there is no force applied to theface of the Guard.

Referring now to FIG. 1, there is shown an exemplary Needle Guard 1assembled on a hypodermic Needle 2. As shown, the Guard 1 is sized fitand permanently assembled onto the Needle body 3 of the Needle 2. TheGuard may be optionally interference fit on a Hypodermic Needle. TheNeedle Guard 1 is positioned on the body of the Needle 3 and have arms 9around Needle Shaft 4. In this embodiment, locking features are providedby way of Shaft locks (or retention feature) 5 positioned around theNeedle Shaft 4, which in the embodiment can also hold the Guard 1 in apartially open position. In an embodiment, a partially open, or lessopen, position can be defined by grooves on tabs extending from theArms. These grooves allow the Needle to slip in and out of a lockposition by means of a two way feature. The bidirectional feature can beachieved by means of reduced lead-ins and a shallower depth. There isalso shown pinch locations 6 on Guard 1 that can be used to applypressure thereon to close Guard 1 around Needle Shaft 4, when Needle 2has been used and is ready for disposal. Front face 7 on Guard 1 isadditionally shown, along with relief cutouts 8 in arms 9 that canaccommodate Shaft locks 5 to occupy when Guard 1 is in a more openposition, such as when the Guard is fully open.

Referring now to FIG. 2, there is shown an isometric view of Guard 1with the orientation of the pinch locations 6 shown in top and bottompositions. This view shows Shaft locks 5 and Guard 1, arm 9 and cutouts8 from a second viewpoint. Also shown are integral hinges 11 in the arms9 that in the embodiment allow Guard 1 to flex open and closed duringits use in different positions. As shown Guard 1 has front face 7,showing that Needle 2 may pass through hole 10 when Guard 1 opens into asecond positon.

FIG. 3 is a top view of Guard 1 and Needle 2. It shows the Guard body,arms 9, pinch locations 6, relief cutouts 8, integral hinges 11 andfront face 7. Additionally it shows the Needle 2, Needle body 3 and Luerlock feature of this embodiment.

FIG. 4 shows the front face of the Needle Guard 1 and Needle 2 assembly.This view shows Guard 1's front face 7, pinch locations 6 and body ofNeedle 1. Needle Shaft 4 can also be seen in the center of the frontface 7 and through Needle through hole 10.

FIG. 5 is a rear view of Guard 1 and Needle 2 assembly. There is shown adouble D shape of the Needle body 3 and the primary central location ofNeedle Shaft 4. Also shown is pinch locations 6. in this embodiment, thedouble-D shape is the feature that mounts in the Luer lock 14 and on ahypodermic Needle body 3.

In FIGS. 6 and 7, there are section views of the assembly in a first,pre-use position of an embodiment. This view shows a assembled assemblyof Needle body 3 and Needle Guard 1. Central Needle Shaft 4 and itsrelationship to Needle Guard 1 can also be seen. The section view alsoshows Shaft locks 5 configured around Needle Shaft 4, and it showsNeedle Tip 12 within the Guard 1 body proximate to front face 7 andpositioned to pass through hole 10. This positioning of Needle Tip 12 inthe through hole 10, but not extending past the hole, in this positionmeans that the Tip 12 is protected and users are protected fromaccidental sharps injury. As configured and shown, the Tip 12 cannot beaccessed without locks 5 releasing Needle Shaft 4 and front face 10moving backwards away from Needle Tip 12 towards the Needle body 3. Whenlocks 5 release from Shaft 4, arms 9 on Guard 1 can flex by means ofintegral hinges 11.

FIG. 8 shows a side view of Guard 1 and Needle 2 assembly, showingfeatures of Guard 1. It can be seen body 1, arms 9, integral hinges 11,cutouts 8 in arms 9, pinch locations 6, Needle Shaft locks 5, Needle Tip12, Needle Shaft 4 and front face 7. This view also shows an embodimentwith integral hinges 11 as thinned sections of arms 9. This thinnedsection of hinge 11 allows the plastic in an arm 9 to flex in a specificlocation, which may be adjust along arm 9 as desired.

FIG. 8 further shows arms 9 in their initial molded or formed concaveposition. This position provides the initial form for arms 9 to moveaway from. For example, when pressure is applied to the front face 7 ofGuard 1, Shaft locks 5 release Shaft 4 and arms 9 of Guard 1 begin toopen. In the embodiment shown, opening is the movement of arms 9 so thatthe angle between them decreases. Their initial form have portions ofarms 9 in a substantially flat, or substantially 180 degrees,orientation, with perhaps a small concave relative to Needle Shaft 4 asshown. When arms 9 open, portions of an arm 9 will start to fold as theportions of each arm 9 become substantially parallel.

FIG. 9 shows a section view of the assembly in an open, or second,position. Here portions of each Guard arms 9 are closer to parallel toone another and the angle between them is closer to zero. As shown,Shaft locks 5 are positioned so that they can occupy complementarycutouts 8 in arms 9. As shown, Shaft locks 5 in this embodiment has twoposition locks features. In an embodiment, the lock features can have afirst groove in a tab on an arm that has a shallow angled feature on itallows a needle to slide in and out of it multiple times. The tab canalso have the ability of flexing with respect to the arm. The lockfeatures can have a second feature which is configured for use as a lockposition, which can have steeper angles on it that prevent the needleshaft from sliding in and out once engaged. So for example, when aneedle shaft comes in contact with an angled surface it will be able tomove over it. When the shaft comes in contact with a surfaceperpendicular to it between 45 and 90 degrees the shaft will stop andlock. Such surfaces can be used as locking elements of the embodiment,and allow the Guard to lock and unlock on the Needle.

Referring to FIGS. 10 and 11, there is shown a section view of Guard 1on Needle 2, in a third position of the assembly after use and pressureis applied on indentation 6 to close Guard 1 around Needle Shaft 4again. This view shows the Shaft locks 5 positioning onto the NeedleShaft 4. These locks position from the position shown in FIG. 9 to theposition shown in FIGS. 10 and 11, where Needle Shaft 4 moves pastgrooves 14 and into permanent lock groove 13 of locks 5. In anembodiment, grooves 13 are configured so that once Shaft 4 is pushedinto grooves 13, Guard 1 will not open again merely by pressing againstface 7 of the Guard (in contrast to when Shaft was in the grooves 12 ofthe initial position shown in FIG. 8.

FIG. 11 shows the two positions of the Needle Shaft lock 5 in anembodiment. Positon 1 (shown as 12) can be used during the storage,transport or use of the Needle and can be engaged and disengagedrelatively easily. Position 2 (shown as 12) is a more permanent lock onthe Needle Shaft 4. This more permanent position is achieved by means ofpressing on the finger indentations 6 towards the Needle Shaft 4, tolock the Guard on the Needle so as to resist further use of the Needleas the more permanent position of the lock 5 resist further exposure ofNeedle Tip 12 past Guard face 7.

FIG. 12 shows a Needle Guard 1 and Needle 2 in an exploded view beforethey are assembled together, such as by permanently bonding.

FIG. 13 shows a Needle Guard 1 and Needle 2 assembly, about to beinstalled on a hypodermic Needle body 15.

FIG. 14 shows a Needle Guard 1 and Needle 2 installed on a hypodermicNeedle 15.

FIG. 15 shows a section view of an assembled Needle Guard and Needle,showing that the Needle body 3 is locked into and on a Luer lock 14 ofhypodermic Needle body 15.

FIG. 16 shows the Needle and Guard in the partially open position,showing the shapes on the Guard arm with the shaft lock 5 and asecondary lock guard feature 16. As can be seen, the lock guard feature16 of this embodiment work with groove 13 to lock Needle Shaft 4 onceShaft 4 moves past groove 14, such that Guard 1 will not open againmerely by pressing against face 7 of the Guard (once the Needle Shaft 4is within groove 13 and lock guard feature 16).

FIG. 17 shows the Needle Guard in the partially open position, such aswhile moving from a less open position to a more open position. In anembodiment where it is an integrated product, the Needle may bemanufactured with the Guard and thereby configured so as it cannot beremoved from the body. In an embodiment, the hub surround Guardincorporates the slip and twist luer lock features of the hypodermicneedle hub.

FIG. 18 shows another embodiment of a Needle Guard assembly in apartially open position. In the embodiment, alternate shaft locking, orretention, features are shown for capturing a Needle shaft 4. In theembodiment, the locking or retention features are shown as retentionfeatures arms, or capture arms, 17 and 18, with a primary lock captureor retention feature (such as a first groove) on one arm 17 and thesecondary lock capture or retention feature (such as a second groove) onthe second arm 18. In this embodiment, the splitting of retentionfeatures into two independent arms creates multiple forces that captureand lock the Needle 4 into differing use positions. In the embodiment,first and second arms 17 and 18 are configured to provided lock capturefeatures (such as grooves) at different distances from arm 9, to providemulti-stage position holding or locking.

FIG. 19 shows a top view of the alternate embodiment of a Needle Guardin the closed, or partially locked, position. The view shows the featureretention arms 17 and 18 capture of a Needle Shaft 4 by into a firstposition where Shaft 4 is within the retention feature (such as agroove) of arm 17, but before the locking feature (such as a groove) ofarm 18.

FIG. 20 shows a section view of the Needle Guard assembly of FIG. 19 ina partially locked position. In this view the Needle Shaft 4 is shown ina first position held by the retention feature of an arm 17. As shown,the secondary lock position has not been engaged, but can be upon arms 9being compressed to engage the retention feature of arm 18.

It will be appreciated that additional arms and/or locking feature maybe used. For example, FIG. 21 shows a detailed isometric view of anotherembodiment of a Needle Guard's shaft capturing features. In theembodiment shown, three retention features, or capture, arms 20, 23 and24 are shown, each having thereon grooves 21 and 22. In the embodiment,grooves 21 and 22 provide primary and secondary locks to capture aNeedle Shaft 4 into first and secondary locked positions as arms 9 arecompressed as described above.

The present invention has been described with regard to preferredembodiments. However, it will be obvious to persons skilled in the artthat a number of variants and modifications can be made withoutdeparting from the scope of the invention as described herein.

The invention claimed is:
 1. A guard apparatus for a hypodermic needle,the guard comprising: a needle surround adapted to a needle shafttherethrough, at least two arms of molded plastic extending from theneedle surround, each arm of the at least two arms moveable from a firstposition wherein each arm of the at least two arms runs substantiallythe length of the needle shaft, and a second position wherein the atleast two arms bring the needle surround around the needle shaft toallow a portion of the length of the needle shaft therethrough, each ofthe at least two arms having: a first hinge positioned proximate to theneedle surround and a second hinge positioned further along each armdistal from the first hinge, the first hinge and second hinge having athinned section of plastic that is more flexible than other sections ofthe at least two arms and manufactured with forms creating intrinsicvarying spring values to facilitate reshaping of each arm of the atleast two arms from the first position to the second position; a firstretention feature positioned on at least one of the at least two arms toremovably engage with the needle shaft when the at least two arms are inthe first position, and when the first retention feature is removablyengaged with the needle shaft, the first retention feature providing aresistive force against moving the at least two arms from the firstposition of the at least two arms running substantially along the lengthof the needle shaft, to the second position, and wherein upon areleasing force overcoming the resistive force is applied, the firstretention feature is disengaged from the needle shaft to permit the atleast two arms to move to the second position; and a second retentionfeature engageable with the needle when the at least two arms are movedto a third, locked position, wherein the second retention featureprovides a locking force greater than the releasing force for the firstretention feature, to maintain the at least two arms in a lockedposition whereby the at least two arms runs substantially along thelength of the needle shaft, wherein the first and second retentionfeatures are each a groove molded onto a retention feature arm extendingfrom the at least one of the at least two arms, which retention featurearm is molded together with the at least one of the at least two arms,and wherein the second retention feature is closer to the at least oneof the at least two arms than the first retention feature.
 2. The guardapparatus of claim 1, wherein the needle surround is molded plastic, andmolded together with the at least two arms.
 3. The guard apparatus ofclaim 2, wherein the guard apparatus is integrated with a needle bodyhousing of the hypodermic needle connected to the needle shaft.
 4. Theguard apparatus of claim 2, wherein the guard apparatus is attachable toa needle body housing of the hypodermic needle connected to the needleshaft.
 5. The guard apparatus of claim 4, wherein the guard apparatus isattachable to the needle body housing by a Luer lock.